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New treatment option for Recurrent Pericarditis
Official title An Open-Label Pilot Study of VTX2735 in Recurrent Pericarditis
ClinicalTrials.gov ID: NCT06836232
What this study is testing
What is VTX2735?
VTX2735 is an investigational medicine, given as an once-daily, being studied as a potential treatment for recurrent pericarditis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a study to understand if taking VTX2735 is safe and effective in participants diagnosed with Recurrent Pericarditis (RP). Cohort A will include approximately 10 participants and will consist of the following: A 30-day Screening Period (to see if a participant qualifies for the study) A 6-week Open Label Treatment Period - participant receives VTX2735 Dose A A 7-week Extension Treatment Period (if a participant meets criteria for extension treatment) - participant receives VTX2735 Dose A An 11-week Once Daily Treatment Period (if a participant meets criteria for this treatment period) - participant receives VTX2735 Dose B A 14-day Follow-Up Period Cohort B will include approximately 20 participants and will consist of the following: A 30-day Screening Period (to see if a participant qualifies for the study) A 6-week Open Label Treatment Period - participant receives VTX2735 Dose B or C An 18-week Extension Treatment Period (if a participant meets criteria for extension treatment) - participant receives VTX2735 Dose B or C A 14-day Follow-Up Period Cohort C will include approximately 20 participants and will consist of the following: A 30-day Screening Period (to see if a participant qualifies for the study) A 6-week Open Label Treatment Period - participant receives VTX2735 Dose D or E, and B An 18-week Extension Treatment Period (if a participant meets criteria for extension treatment) - participant receives VTX2735 Dose B A 14-day Follow-Up Period
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Participants are male or female ≥ 18 years up to ≤ 75 years of age.
- Capable of giving signed informed consent and able to comply with the protocol
- Previously had an index (first) episode of pericarditis which met the criteria for an acute pericarditis event
- Ongoing symptomatic episode of pericarditis, or may have an episode of recurrent pericarditis in the next 4 weeks.
- CRP by local laboratory assessment prior to first dose of study treatment (participants with CRP ≤ 10 mg/L must be receiving corticosteroid treatment...
You likely can't join if
- Current or prior diagnosis of pericarditis that is secondary to specific prohibited causes, including but not limited to tuberculosis, blunt trauma...
- History of clinically significant immunosuppressive disorder, autoimmune/autoinflammatory disorder, or primary or secondary immunodeficiency.
- Clinically important history of a medical disorder that would compromise safety or data quality, per the Investigator's judgment.
See the full eligibility criteria
- Participants are male or female ≥ 18 years up to ≤ 75 years of age.
- Capable of giving signed informed consent and able to comply with the protocol
- Previously had an index (first) episode of pericarditis which met the criteria for an acute pericarditis event
- Ongoing symptomatic episode of pericarditis, or may have an episode of recurrent pericarditis in the next 4 weeks.
- CRP by local laboratory assessment prior to first dose of study treatment (participants with CRP ≤ 10 mg/L must be receiving corticosteroid treatment for RP and have evidence of pericardial inflammation)
- Pericarditis pain score ≥ 4 based on the 11-point NRS.
- Stable doses of NSAIDs, colchicine, and/or oral corticosteroids (if receiving these treatments)
- Current or prior diagnosis of pericarditis that is secondary to specific prohibited causes, including but not limited to tuberculosis, blunt trauma, tumor, myocarditis, or systemic autoimmune diseases.
- History of clinically significant immunosuppressive disorder, autoimmune/autoinflammatory disorder, or primary or secondary immunodeficiency.
- Clinically important history of a medical disorder that would compromise safety or data quality, per the Investigator's judgment.
The study team makes the final eligibility decision.
Where it's taking place
- Tucson, Arizona, United States
- Orange, California, United States
- Saint Augustine, Florida, United States
- Chicago, Illinois, United States
- Park Ridge, Illinois, United States
- Owensboro, Kentucky, United States
- Boston, Massachusetts, United States
- Rochester, Minnesota, United States
- New York, New York, United States
- Cleveland, Ohio, United States
- Houston, Texas, United States
- Salt Lake City, Utah, United States
- Burlington, Vermont, United States
- Charlottesville, Virginia, United States
- Richmond, Virginia, United States
- Seattle, Washington, United States
- Ottawa, Ontario, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tucson, Arizona, United States; Orange, California, United States; Saint Augustine, Florida, United States; Chicago, Illinois, United States; Park Ridge, Illinois, United States; Owensboro, Kentucky, United States and 11 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.